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Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO

Primary Purpose

ARDS, Acute Lung Injury, Extracorporeal Membrane Oxygenation

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Ultra-protective ventilator settings
Standard ventilator settings
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ARDS focused on measuring ARDS, ECMO, Ventilation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg
  • ECMO < 24 hours in situ
  • Gender-matched
  • Age-matched

Exclusion Criteria:

  • BMI > 40
  • Expected weaning of ECMO < 3 days (postoperative ECMO)
  • Combustion
  • Restrictive chest wall impairment
  • Pregnancy

Sites / Locations

  • Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Ultra-protective ventilator settings in patients with ARDS and ECMO.

Standard ventilator settings in patients with ARDS and ECMO.

Outcomes

Primary Outcome Measures

Ventilator free days
Ventilator free days
Time from randomization to fulfillment of extubation criteria
Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria: ARDS resolved Temperature ≥ 36°C and ≤ 39°C Low FiO2 (< 0.5) PEEP (< 8 cmH2O) requirement Able to initiate spontaneous breaths Tidalvolume > 5 mL/kg or > 325 mL Minute ventilation 5-6 L/min PaO2/FiO2 > 200 mmHg pH ≥ 7.25 Ability to cough after deflating tube cuff Respiratory rate 8-30/min Hemodynamic stability

Secondary Outcome Measures

Total time of mechanical ventilation
Total time of mechanical ventilation
28 day mortality
Mortality from initiation of ECMO till day 28 after initiation of ECMO
One year mortality
Mortality from initiation of ECMO till one year after initiation of ECMO
Incidence of reintubation
Incidence of reintubation
Length of ICU stay
Length of ICU stay
Evaluation of RAS, ACE, ACE2.
Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.
Evaluation of Cytokines in pg/ml
IL-6, IL-8, TNFR1, RAGE, Protein C

Full Information

First Posted
November 29, 2018
Last Updated
September 13, 2021
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03764319
Brief Title
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO
Official Title
Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With Severe Acute Respiratory Distress Syndrome and Extracorporeal Membrane Oxygenation: a Prospective, Randomized, Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 6, 2018 (Actual)
Primary Completion Date
August 1, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The acute respiratory distress syndrome (ARDS) is the most severe form of respiratory failure, presented in 10% of all intensive care patients and carrying a high mortality rate. Extracorporeal membrane oxygenation (ECMO) is a rescue treatment for patients with severe ARDS. Mechanical ventilator settings in patients with severe ARDS during ECMO therapy are not clearly defined at the moment.
Detailed Description
The aim of this study is to assess the effect of a rigorous low breathing frequency and ultra-low tidal volume ventilation strategy on clinical outcome, compared to standard ventilator settings following the recent guidelines in patients with severe ARDS treated with ECMO. The hypothesis is that a low breathing frequency and ultra-low tidal volume ventilation strategy is more protective for the ARDS challenged lung and reduces the duration of mechanical ventilation and so increases the ventilator free days in patients with severe ARDS treated with ECMO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, Acute Lung Injury, Extracorporeal Membrane Oxygenation, Respiratory Distress Syndrome, Respiratory Tract Diseases, Lung Diseases, Lung Injury, Acute
Keywords
ARDS, ECMO, Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of 2 groups
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
Ultra-protective ventilator settings in patients with ARDS and ECMO.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Standard ventilator settings in patients with ARDS and ECMO.
Intervention Type
Other
Intervention Name(s)
Ultra-protective ventilator settings
Intervention Description
4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 < Plateau pressure < 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume > 4 mL/kg Predicted body weight (PBW)); < 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E)
Intervention Type
Other
Intervention Name(s)
Standard ventilator settings
Intervention Description
12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
Primary Outcome Measure Information:
Title
Ventilator free days
Description
Ventilator free days
Time Frame
Immediately after initiation of ECMO up to 28 days
Title
Time from randomization to fulfillment of extubation criteria
Description
Time from randomization (initiation of ECMO) to fulfillment of the extubation criteria: ARDS resolved Temperature ≥ 36°C and ≤ 39°C Low FiO2 (< 0.5) PEEP (< 8 cmH2O) requirement Able to initiate spontaneous breaths Tidalvolume > 5 mL/kg or > 325 mL Minute ventilation 5-6 L/min PaO2/FiO2 > 200 mmHg pH ≥ 7.25 Ability to cough after deflating tube cuff Respiratory rate 8-30/min Hemodynamic stability
Time Frame
Immediately after initiation of ECMO up to 28 days
Secondary Outcome Measure Information:
Title
Total time of mechanical ventilation
Description
Total time of mechanical ventilation
Time Frame
Start of mechanical ventilation up to 28 days
Title
28 day mortality
Description
Mortality from initiation of ECMO till day 28 after initiation of ECMO
Time Frame
Immediately after initiation of ECMO up to 28 days
Title
One year mortality
Description
Mortality from initiation of ECMO till one year after initiation of ECMO
Time Frame
Immediately after initiation of ECMO up to one year
Title
Incidence of reintubation
Description
Incidence of reintubation
Time Frame
Immediately after initiation of ECMO up to 28 days
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
Immediately after initiation of ECMO
Title
Evaluation of RAS, ACE, ACE2.
Description
Analyses of leftover blood. Renin angiotensin system (RAS) and Angiotensin converting enzyme (ACE) evaluation.
Time Frame
2 months
Title
Evaluation of Cytokines in pg/ml
Description
IL-6, IL-8, TNFR1, RAGE, Protein C
Time Frame
2 months

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe ARDS - Partial pressure of oxygen/Fraction of inspired oxygen (PaO2/FiO2) < 200 mmHg ECMO < 24 hours in situ Gender-matched Age-matched Exclusion Criteria: BMI > 40 Expected weaning of ECMO < 3 days (postoperative ECMO) Combustion Restrictive chest wall impairment Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ullrich, Ao.Univ.Prof.
Organizational Affiliation
Department of Anesthesia and Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna - Division of General Anaesthesia and Intensive Care Medicine
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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Low Frequency, Ultra-low Tidal Volume Ventilation in Patients With ARDS and ECMO

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